—#213603

Product

ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.

FDA product code: NHX — Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K083868
Affected lot / code info: Catalog No. 09P2720; GTIN: 380740151362; Order No. 46050138.

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.

Root cause (FDA determination)

Storage

Action the firm took

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.

Recalling firm

Firm: Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Distribution

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

Timeline

Recall initiated: 2025-04-24
Posted by FDA: 2025-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213603. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.