The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0561-2016·Announced 2016-01-06

Beckman Coulter MicroScan Pos Breakpoint Combo Panel Recall

Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20 due to falsely negative Voges-Proskauer results.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving diagnostic equipment that could lead to incorrect clinical decisions, although no specific hospitalization reports are cited in the text.

Plain-English summary

Beckman Coulter Inc. is recalling MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202. The recall involves 751 units total, with 701 units distributed in the United States and the remainder distributed worldwide to specific countries 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.

The recall was initiated because the company confirmed falsely negative results for Voges-Proskauer (VP) tests using the Quality Control American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of the affected lots. The expected result for this test is positive. These 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 fastidious aerobic gram-positive cocci, and Listeria monocytogenes.

Users of these panels should stop using the affected lots and contact Beckman Coulter for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 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…
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)

  • 2016-04-30 Part No. B1017-202

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