Exact FDA event identifier

Event 73027

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 24, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: bioMerieux, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).

Z-0749-2016

Recall number: Z-0749-2016
Initiated: December 24, 2015
Classification: Class II
Status: Terminated
Recalling firm: bioMerieux, Inc.
Quantity: 2741 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

Code information

Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.

Distribution pattern

Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.

device · product 2 of 2

BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).

Z-0750-2016

Recall number: Z-0750-2016
Initiated: December 24, 2015
Classification: Class II
Status: Terminated
Recalling firm: bioMerieux, Inc.
Quantity: 2741 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

Code information

Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.