The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1586-2022·Announced 2022-08-31

ABX PENTRA Creatinine Reagent Recalled Due to Temperature Excursion Exposure

Mckesson Medical-Surgical is recalling ABX PENTRA Creatinine reagent due to facility temperature excursions (June-August 2021) that may have impacted product effectiveness. Affected lots were received nationwide between June 1 and September 30, 2021.

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: This FDA Class II recall involves a medical device where temperature exposure may have impacted product effectiveness. As a clinical chemistry reagent affecting diagnostic accuracy, compromised effectiveness represents a potential risk to patient care through misdiagnosis. The score reflects this risk-of-harm nature despite the lack of reported adverse events.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling ABX PENTRA CREATININE 120CP JAFFE clinical chemistry reagent (Model Number: 1220001933, Reference: A11A01933) nationwide.

The recall is due to facility temperature excursions occurring between June 2021 and August 2021 prior to product delivery. Exposure to higher temperatures may have impacted the product's effectiveness.

The recall affects all lots received between June 1, 2021, and September 30, 2021. This reagent is used in clinical laboratories for creatinine testing.

Healthcare facilities and laboratories that received affected lots should contact Mckesson Medical-Surgical Inc. for further instructions regarding product replacement or verification of reagent integrity before continued use.

The recalled product

Product
a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Clinical Chemistry Reagent
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)

  • GTIN: 03610230005736 Lots Distributed: 5/30/2021 - 9/8/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 55 products in this recall →

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