FDAClass IIAugust 31, 2022

A. ABX Pentra Creatinine 120cp Jaffe 120/130 recall

a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933

Why was A. ABX Pentra Creatinine 120cp Jaffe 120/130 recalled?

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
a. 28 b. 22
Distribution
US Nationwide
Recall date
August 31, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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