Recall Z-0933-2022 ยท DKB Calibrators, Drug Mixture
MEDLINE INDUSTRIES, LP - Northfield
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
| Date | Mar 8, 2022 |
| Status | Terminated |
| Reason | The product was stored incorrectly due to improper storage controls which may lead to delayed results. |
| Root cause | Storage |
| Action | The recalling firm issued letters dated 3/8/2022 via regular mail on 3/8/2022. The letter explained the product was stored incorrectly due to improper storage controls. The consignee was to immediately check their inventory for the affected lot numbers, quarantine it, and destroy it. The enclosed destruction form was to be completed listing the quantity of affected product destroyed and once the form was returned, they would receive credit. If the product was transferred to another individual or location, they were to notify them of the recall communication. On 3/17/2022, the recalling fi |
| Quantity | 10 boxes |
| Distribution | Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.