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U.S. Department of Health and Human Services

Class 2 Device Recall Stanbio TDM/ Hydroxybutyrate Linearity Standards

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  Class 2 Device Recall Stanbio TDM/ Hydroxybutyrate Linearity Standards see related information
Date Initiated by Firm March 08, 2022
Create Date April 14, 2022
Recall Status1 Open3, Classified
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/
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
Manufacturer Reason
for Recall
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
FDA Determined
Cause 2
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

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.