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FDA (Device enforcement)Recalled 2022-05-25class ii

Mckesson Medical-Surgical Inc. Corporate Office: a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Ra

Is my product affected?

a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST

  • UPC 10612479218625
  • UPC 20612479202768
  • UPC 10612479218618
  • UPC 20612479202751
  • UPC 10612479218601
  • UPC 20612479202744

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling three rapid test kits: the McKesson Rapid Test Kit, McKesson Consult Fertility Test, and hCG Pregnancy Test (Serum/Urine Sample 25 Tests, Model Number 5002). The recall affects specific product lots received between June 1, 2021 and September 30, 2021, distributed nationwide. The products were exposed to temperature excursions between June and August 2021 prior to delivery, which may have impacted their effectiveness.

The recall involves a total of 2,171 units across the three test kits, identified by specific GTINs and lot numbers. The affected lots include all units received during the specified timeframe with the listed product codes. The recall record does not specify a remedy or action that consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: a. 108 b. 838 c. 1225 Lot/code info: GTIN: 10612479218625; 20612479202768 all lots and expiration dates received during July 4th through September 30th, 2021. b. GTIN: 10612479218618; 20612479202751 All lots received between 7/4/21-9/30/21. c. GTIN: 10612479218601; 20612479202744

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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