Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen s
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling cobas b 123 Fluid Pack COOX cuvettes with lot numbers 21426121 and 21426171. These cuvettes, used with the cobas b 123 POC system for blood testing, exhibit a significantly increased out-of-box failure rate. The failures were caused by a change in cuvette layer thickness resulting from production equipment settings. The affected product (part number 05169992001) was distributed nationwide, including to locations in the Northeast and Arizona, with 23 units of the 200-count fluid packs distributed.
The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper
Reason for recall: It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper Distribution: Nationwide Distribution including NE and AZ. Quantity: 23 units of Fluid Pack COOX, 200 were distributed Lot/code info: Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.