McKesson blood coagulation test kits recalled for temperature storage damage
McKesson recalls Coag-Sense blood coagulation test kits nationwide due to facility temperature excursions that may have affected test effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a risk-of-harm diagnostic device where no illnesses or injuries have been reported. Temperature exposure may have compromised test effectiveness, creating theoretical risk of inaccurate results.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Coag-Sense Professional Blood Coagulation Test (PT/INR) kits and control kits distributed nationwide. The recall covers 27 boxes of test kits (part number 0356-50) and 1 box of control kits (part number 03P69-10) distributed between June 1 and September 30, 2021.
The products were exposed to temperature excursions at the manufacturing facility between June and August 2021 prior to shipment. These elevated temperatures may have impacted the effectiveness of the test kits.
Healthcare providers and laboratories that received these recalled products should discontinue use and contact McKesson Medical-Surgical for replacement units or further instructions.
The recalled product
- Product
- a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- compromised-effectiveness
- temperature-storage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- a. GTIN: 00861900000336
- 10861900000395
Distribution
Distributed nationwide across the United States.
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