Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used

FDA device recall Z-0110-2013 · posted 2012-10-22 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.

Action taken

Beckman Coulter sent an Urgent Product Correction letter dated December 15, 2011, withan attached Fax Back Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. If customers are currently using Multi Calibrator lot M002642, then they were instructed to verified diskette and discard all Multi Calibrator diskettes lot M002642 and M002642G without a dark green dot. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers were instructed to contact Beckman Coulter Support Center at http:www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada. Outside of the US or Canada, customers were instructed to contact their local Beckman Coulter Representatives. For questions regarding this recall call 714-961-4483.

Root cause

Labeling mix-ups

Status

Terminated

Product code

JIX

Quantity affected

5746 units total (2729 units in US)

Distribution

Worldwide distribution: USA (Nationwide) and Internationally to: Afghanistan Angola Australia Bangladesh Belgium Bhutan Brazil Brunei Darussalam Bulgaria Canada China Colombia Costa Rica Cote d'Ivoire

Date initiated

2011-12-15

Date posted

2012-10-22

Date terminated

2012-12-28

Location

Brea, CA

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