a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sam
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling MMS-Immunostics Inc. McKesson Rapid Test Kits for colorectal cancer screening (fecal occult blood tests). The recall affects all lots received between June 1, 2021, and September 30, 2021. The kits were exposed to higher-than-appropriate temperatures at a facility between June and August 2021 prior to delivery, which may have reduced the product's effectiveness at detecting blood in stool samples.
The affected test kits were distributed nationwide. The specific products involved include multiple lot/code combinations identified by their GTINs. The recall notice does not specify a remedy or action for consumers who have these products.
Written by software from the official notice below. Not reviewed by a lawyer.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Reason for recall: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Distribution: US Nationwide Quantity: boxes: a. 20 b. 21 c. 4 Lot/code info: GTIN: a. 10612479219417; 20612479198368. b. 10612479226132; 20612479225569. c. 10612479226125; 20612479225552
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.