S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagn

FDA device recall Z-2330-2015 · posted 2015-08-05 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.

Action taken

Roche Diagnostics sent an Urgent Medical Device Correction dated July 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to do the following: 1. Keep in the inventory a backup S2 Fluid Packs from an unaffected lot, or at least four additional S2 Fluid Packs from the affected lots when product from unaffected lots is not available. 2. If the S2 Fluid Pack generates a Transponder error message, contact the Roche Support Network Customer Support Center at 1-800-526-2272 (provide the lot and serial number printed on the side of the affected S2 Fluid Pack). 3. After contacting Roche Support Network Customer Support Center, dispose of the affected S2 Fluid Pack per local guidelines. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272, if you have questions about the information contained in this Urgent Medical Device Correction.

Root cause

Process control

Status

Terminated

Product code

CHL

Quantity affected

19 affected devices of lot 21450781 were distributed in the US.

Distribution

US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.

Date initiated

2015-06-24

Date posted

2015-08-05

Date terminated

2016-01-12

Location

Indianapolis, IN

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