ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.

FDA device recall Z-1851-2025 · posted 2025-05-27 · Open, Classified

Recall details

Recalling firm

Mckesson Medical-Surgical Inc. Corporate Office

Reason for recall

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.

Action taken

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 MMSQARecalls@McKesson.com 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.

Root cause

Storage

Status

Open, Classified

Product code

JIT

Quantity affected

1 unit

Distribution

US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.

Date initiated

2025-04-24

Date posted

2025-05-27

Location

Richmond, VA