The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1476-2014·Announced 2014-04-30

BioMerieux Recalls FB Reagent Due to False Negative Test Results

BioMerieux SA is recalling FB Reagent (REF 70562) and ZYM B reagent (REF 70493) because a visual defect and activity issue can cause false negative results in Rapid ID 32 and API biochemical tests.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves false negative results in diagnostic tests, which poses a risk of harm to patients through misdiagnosis, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

BioMerieux SA is recalling FB Reagent (REF 70562) and ZYM B reagent (REF 70493). The recall involves 33,853 units of FB Reagent distributed nationwide in the United States, including DC and Puerto Rico, as well as to numerous countries worldwide.

The recall was initiated because BioMerieux identified a visual defect and an activity issue in the affected reagents. This activity issue can lead to false negative results when using the ZYM B reagent or FB reagent with Rapid ID 32 strips and API biochemical tests. These test systems are used to identify microorganisms.

Healthcare facilities and laboratories should stop using the affected lots immediately. The specific lot codes and expiration dates for the recalled FB Reagent are: 1002717180 (Exp. 5/30/2014), 1002737220 (Exp. 6/13/2014), 1002778550 (Exp. 8/9/2014), 1002782960 (Exp. 8/15/2014), 1002792840 (Exp. 8/15/2014), 1002834130 (Exp. 8/22/2014), and 1002877370 (Exp. 8/22/2014). Users should contact BioMerieux SA for instructions on returning the product.

The recalled product

Product
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests…
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
33,853

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Codes - 1002717180
  • Exp. Date 5/30/2014
  • 1002737220
  • Exp. Date 6/13/2014
  • 1002778550
  • Exp. Date 8/9/2014
  • 1002782960
  • Exp. Date 8/15/2014
  • 1002792840
  • 1002834130
  • Exp. Date 8/22/2014
  • 1002877370

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 4 recalled by BioMerieux SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · BioMerieux SA

See all →

Same hazard · false negative result

See all →

Similar recalls