The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2095-2017·Announced 2017-05-24

BioMerieux Recalls ETEST ETP32 Ertapenem Strips Due to False Results

BioMerieux SA is recalling ETEST ETP32 (Ertapenem) strips because they may produce false susceptible results, potentially leading to incorrect antibiotic treatment.

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 test results that could lead to incorrect antibiotic therapy, which is a significant risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

BioMerieux SA is voluntarily recalling ETEST ETP32 (Ertapenem) strips, reference number 531640. The recall affects 3,238 units distributed nationwide to laboratories in 47 states and the District of Columbia. The specific lot numbers involved are 1003149850, 1003157690, 1003585350, 1003732380, 1003910410, 1004142070, 1004113370, 1004325260, 1004382730, 1004482780, 1004785720, 1004890160, 1005134380, 1005134390, 1005357180, and 1005442470. Reference number 531600 was not distributed in the United States.

The recall was initiated because the ETEST strips may produce false susceptible results. ETEST is a quantitative technique used to determine the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. False susceptible results could lead to the selection of an antibiotic that is not effective against the specific bacterial infection, potentially resulting in inadequate treatment.

Healthcare facilities and laboratories that have received these products should stop using the affected ETEST ETP32 strips immediately. Users should contact BioMerieux SA for instructions on returning the product or obtaining a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
Manufacturer
BioMerieux SA
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
3,238

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 (16)

  • REF 531640  Lot Number - 1003149850
  • 1003157690
  • 1003585350
  • 1003732380
  • 1003910410
  • 1004142070
  • 1004113370
  • 1004325260
  • 1004382730
  • 1004482780
  • 1004785720
  • 1004890160
  • 1005134380
  • 1005134390
  • 1005357180
  • 1005442470 --- REF 531600 - was not distributed in the United States

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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