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This troubleshooting guide is for help purposes only.It does not replace the package inserts, user manual, and instructions for use.The latest versions of these documents are available on the Resource Center: resourcecenter.biomerieux.com

INTERNAL USE ONLY

  • Functional Defect: A defect that affects the fit, form, or function of the bottle, rendering it unusable for the customer. bioMérieux advises against using bottles with functional defects.
  • Cosmetic Defect: A defect that only affects the visual appearance of the bottle. Bottles with cosmetic defects can be used.
When found as a single bottle or at low frequency, cosmetic defects do not require escalation. However, if a trend is observed, they should be escalated for manufacturing awareness and decision-making. In case of uncertainty regarding the impact of a defect, we recommend escalating the case for confirmation by Level 2.ESCALATE

INTERNAL USE ONLY

CAP, CRIMP, AND STOPPER

CULTURE MEDIA

LABEL

SENSOR

BOTTLE PLASTIC

VACUUM

INTERNAL USE ONLY

INTERNAL USE ONLY

ON THE STOPPER

ON THE CRIMP

ON THE FLIP CAP

INTERNAL USE ONLY

IT' S FALLEN (it is in the box)

IT' S MISSING (not in the box)

IT'S DEFECTIVE

INTERNAL USE ONLY

YES, IT'S DAMAGED / APPEARS SMALLER

NO, IT'S UNDAMAGED

INTERNAL USE ONLY

IT'S MISSING

IT'S PUNCTURED

INTERNAL USE ONLY

IT'S CUT

IT'S LOOSE

IT'S DENTED OR BUMPED

INTERNAL USE ONLY

IT COULD BE COMPROMISED

IT'S NOT COMPROMISED

INTERNAL USE ONLY

MICROBIAL CONTAMINATION BEFORE INOCULATION

SMALL IRREGULAR PARTICLES WITH NO SIGN OF MICROBIAL CONTAMINATION

OTHER PARTICLES

INTERNAL USE ONLY

VOIDS ARE PRESENT

THERE ARE RUN DRIPS

THERE IS SEEPAGE

SLIGHT DISCOLORATION OF SENSOR

THE SENSOR IS SLANTED / UNEVEN / UNCURED

INTERNAL USE ONLY

YES

NO

INTERNAL USE ONLY

NO

YES

INTERNAL USE ONLY

NO

YES

INTERNAL USE ONLY

COLLAPSED BOTTLE

WAVE IN BOTTLE NECK

BURN MARKS

POLYCARBONATE PARTICLES

NYLON BUBBLES

MATERIAL OUTSIDE OF BOTTLES

HAZE / CLOUDY PLASTIC BOTTLE

SUPERFICIAL SCRATCH

WHITE SEAM LINE

BREAK, CRACK, DEEP SCRATCH

INTERNAL USE ONLY

NO

INTERNAL USE ONLY

YES

≥ 10 mm

< 10 mm

INTERNAL USE ONLY

≥ 2 mm

< 2 mm

INTERNAL USE ONLY

YES

NO

INTERNAL USE ONLY

NO

INTERNAL USE ONLY

YES

NO

INTERNAL USE ONLY

YES

GATE DROOL

BURN MARKS

POLYCARBONATE DEBRIS

NYLON BUBBLES

BULGING (CONVEX ON OPTICAL REGION)

BREAK, CRACK, SCRATCH

INTERNAL USE ONLY

≥ 11 mm

< 11 mm

INTERNAL USE ONLY

PROMINENT / BOW TIE

EMBEDDED / LIGHT

INTERNAL USE ONLY

SOLID

LIGHT

INTERNAL USE ONLY

NO

YES

INTERNAL USE ONLY

INTERNAL USE ONLY

CSNs:

  • 4932 - CSN - BACTALERT - Culture Bottle Two Sensor Anomalies - LES Voids LES Drips Runs
  • CSN 2024-785-0 - BACT/ALERT® BOTTLES - CHANGE NOTIFICATION PROCESS - ACCEPTABLE COSMETIC VARIABILITY
  • CSN 3906 - BACTALERT - Culture Bottles - Two Plastic Bottle Cosmetic Defects.
  • 5292 - CSN - BACT/ALERT Plastic Bottle Impact Testing

INTERNAL USE ONLY

INTERNAL USE ONLY

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT -COLLAPSED - B266

No escalation is needed

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

No escalation is needed

OPERATOR RISK / POTENTIAL FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE CRIMP DEFECT - FUNCTIONAL - B258

POTENTIAL FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE FLIP CAP ISSUE - B380

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

No escalation is needed

CRITICAL FUNCTIONAL DEFECT

Escalate a CRM Case ASAP

ERROR CODES

BOTTLE CONTAMINATION UNINOCULATED - B104

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

No escalation is needed

COSMETIC DEFECT

ERROR CODES

BOTTLE CONTAM UNINOCULATED-PARTICULATE - B214

No escalation is needed

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE SENSOR DEFECT - SEEPAGE - B356

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE STOPPER DEFECT - B111

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE STOPPER DEFECT - MISSING - B270

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE PLASTIC DEFECT -COLLAPSED - B266

COSMETIC DEFECT

ERROR CODES

PLASTIC BOTTLE DEFECT - EXTERNAL DEBRIS - B374

No escalation is needed

Inoculation is disturbed because of a too small piercing zone:

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE PLASTIC DEFECT - B109orBROKEN BOTTLE -B101

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT -COLLAPSED - B266

No escalation is needed

OPERATOR ERROR

The customer must be retrained.No escalation is needed.

ERROR CODES

BOTTLE INOCULATION - B89 orBOTTLE INOCULATION - IMPROPER NEEDLE - B261

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

No escalation is needed

POTENTIAL FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE CRIMP DEFECT - FUNCTIONAL - B258

COSMETIC DEFECT

ERROR CODES

BOTTLE SENSOR DEFECT - LES RUN/DRIP - B269

No escalation is needed

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

No escalation is needed

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE INOCULATION - VACUUM - B260

COSMETIC DEFECT

No escalation is needed

ERROR CODES

BOTTLE SENSOR DEFECT - B110

POTENTIAL FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE PLASTIC DEFECT - BULGING - B265

COULD BE A FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

POTENTIAL FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE CONTAM UNINOCULATED-PARTICULATE - B214

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

No escalation is needed

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

No escalation is needed

SENSOR

POTENTIAL FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

COSMETIC DEFECT

ERROR CODES

BOTTLE BARCODE DEFECT - B100BOTTLE LABEL ABSENT - B105BOTTLE LABEL MISALIGNED - B106LABELING PROBLEM - BOTTLE DOUBLE LABEL - B378LABELING PROBLEM - BOTTLE PULL TAB - B379....

No escalation is needed

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE SENSOR DEFECT - LES VOIDS - B357

FLIP CAP

CRIMP

Classic crimp come with a Flip Cap

Removable crimp for iAST and iLYM bottles (no Flip Cap)

Without

With

STOPPER

SEPTUM

LABEL

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE CRIMP DEFECT - FUNCTIONAL - B258

COSMETIC DEFECT

No escalation is needed

ERROR CODES

BOTTLE FLIP CAP ISSUE - B380

NORMAL VARIABILITY

No need to qualify the case as a TC

Refer to CSN 2024-785

COSMETIC DEFECT

ERROR CODES

BOTTLE CRIMP DEFECT - COSMETIC- B259

No escalation is needed

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

No escalation is needed

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - BUBBLES - B358

No escalation is needed

NORMAL VARIABILITY

No need to qualify the case as a TC

Refer to CSN 2024-785

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE PLASTIC DEFECT - B109

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE BARCODE DEFECT - B100BOTTLE LABEL ABSENT - B105BOTTLE LABEL MISALIGNED - B106LABELING PROBLEM - BOTTLE DOUBLE LABEL - B378LABELING PROBLEM - BOTTLE PULL TAB - B379....

COSMETIC DEFECT

ERROR CODES

BOTTLE SENSOR DEFECT - LES VOIDS - B357

No escalation is needed

COSMETIC DEFECT

ERROR CODES

BOTTLE PLASTIC DEFECT - BUBBLES - B358

No escalation is needed

NORMAL VARIABILITY

No need to qualify the case as a TC

Refer to CSN 2024-785

Weak cap where the ring remains on the septum:

FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

PLASTIC BOTTLE DEFECT - EXTERNAL DEBRIS - B374

POTENTIAL FUNCTIONAL DEFECT

Escalate a CRM Case

ERROR CODES

BOTTLE SENSOR DEFECT - SLANT - B268