Z-1852-2025Class II
Abbott Diagnostics Alinity I Free Psa Us(200test/ea) Reagent
Mckesson Medical-Surgical Inc. Corporate Office / initiated 2025-04-24 / Open, Classified / root cause: labeling and UDI
Mckesson Medical-Surgical Inc. Corporate Office began a recall of ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1852-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product
- Abbott Diagnostics Alinity I Free Psa Us(200test/ea) Reagent.
- Product code
- MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- 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.
- Root cause tag
- labeling and UDI
- FDA root cause
- Storage
- Action
- 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.
- Quantity in commerce
- 2 units
- Distribution
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- Product codes and lots
- Catalog No. 07P9321; GTIN: 380740158330; Order No. 46052126.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1824-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1825-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1826-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1827-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1828-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1829-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1830-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1831-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1832-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1833-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1834-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1835-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1836-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1837-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1838-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1839-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1840-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1841-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1842-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1843-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1844-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1845-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1846-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1847-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1848-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1849-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1850-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1851-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1852-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1853-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1854-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1855-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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