Roche Diagnostics Recalls cobas Integra Albumin Gen.2 Test Kits
Roche Diagnostics is recalling cobas Integra Albumin Gen.2 test kits due to low quality control recovery and invalid calibration.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and the source text does not report any illnesses or injuries.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the cobas Integra Albumin Gen.2 in vitro test kits, catalog number 05166861190. The recall affects 7,032 units, expanded on December 20, 2019, to include 29,696 additional units. The affected lots are #33962301 and #37437301.
The recall was initiated due to low Quality Control recovery and invalid Calibration. This product is used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
The product was distributed nationwide in the United States, including specific states listed in the agency record. Healthcare facilities and laboratories that possess these specific lots should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
- Manufacturer
- Roche Diagnostics Operations, Inc.
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 (1)
- Lot # 33962301. Expanded on 12/20/19 to include lot 37437301
Distribution
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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