The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0559-2016·Announced 2016-01-06

Beckman Coulter MicroScan Pos Combo Panel Recall for False Negative Results

Beckman Coulter is recalling MicroScan Pos Combo panels that may produce falsely negative Voges-Proskauer results for Staphylococcus aureus.

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 and involves a diagnostic device that may produce false negative results, posing a risk of misdiagnosis or delayed treatment, which fits the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Beckman Coulter Inc. is recalling MicroScan Pos Combo Panel Type 33 (Part No. B1017-211) and MicroScan Pos Breakpoint Combo panels. The recall is due to confirmed falsely negative results for the Voges-Proskauer (VP) test when using the Quality Control American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213. The expected result for this test is positive, but the affected lots may show pale-pink, brown, or colorless results.

The affected product is designed for determining antimicrobial agent susceptibility and identification of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci, and Listeria monocytogenes. A total of 2,706 units were distributed, with 1,276 units distributed in the United States. The products were distributed nationwide in the US and to various international locations including Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand, and the United Kingdom.

Healthcare facilities and laboratories should stop using the affected lots and contact Beckman Coulter for instructions on return or 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 health consequences.

The recalled product

Product
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Diagnostic
Hazard

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 (1)

  • 2016-04-29 2016-05-04 Part No. B1017-211

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Beckman Coulter Inc. 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 5 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

See all →

Same hazard · false negative result

See all →

Similar recalls