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.
What this means for you
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
- Hazard
- temperature-excursion
- reduced-effectiveness
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.
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