| Class 2 Device Recall Stanbio TDM/ Hydroxybutyrate Linearity Standards | |
Date Initiated by Firm | March 08, 2022 |
Create Date | April 14, 2022 |
Recall Status1 |
Terminated 3 on February 27, 2023 |
Recall Number | Z-0933-2022 |
Recall Event ID |
89801 |
Product Classification |
Calibrators, drug mixture - Product Code DKB
|
Product | 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. |
Code Information |
Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023. |
Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
|
For Additional Information Contact | Karin Johnson 866-359-1704 |
Manufacturer Reason for Recall | The product was stored incorrectly due to improper storage controls which may lead to delayed results. |
FDA Determined Cause 2 | 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 firm issued an amended recall letter dated 3/17/2022 that notified the consignee there was an error in one of the lot numbers (1747003) listed in the original letter dated 3/8/2022 and the correct lot number is 174703. The other lot numbers were also listed in the amended letter. Again, return of the amended Destruction Form listing all of the lot numbers was requested containing the same instructions as the original Destruction Form. |
Quantity in Commerce | 10 boxes |
Distribution | Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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