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Abbott Point Of Care Test Crea I-Stat (25/Bx) Abbtpt… recallZ-1846-2025 · Mckesson Medical-Surgical Inc. Corporate Office · initiated Apr 24, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mckesson Medical-Surgical Inc. Corporate Office or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

FDA root cause category: Storage

What the company is doing

An URGENT PRODUCT RECALL notification dated 4/21/25 was mailed to consignees. The notification instructs consignees to immediately examine their inventory and quarantine all product identified as subject to this recall action. Consignees are asked to return the completed response form to [email protected] and to destroy any quarantined devices. Questions about this recall can be directed to 1-800-688-8840 from 8:00 am to 5:00 pm Monday through Friday. If product has been further distributed, consignees are asked to forward the provided recall notice to those customers.

Recall details

Recall number
Z-1846-2025
Status
Open, Classified
Initiated by the company
Apr 24, 2025
Posted by the FDA
May 27, 2025
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
25 units
Product code
CGL
FDA submissions
K053110
Distribution
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.

Product description

ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.

Code information (models, lots, serial numbers)

Catalog No. 03P8425; GTIN: 10054749000125; Order No. 46085650.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K053110 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96752).

Sources and updates

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