Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots The Access Total T4 assay is a p

FDA device recall Z-1949-2011 · posted 2011-04-12 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm

Action taken

Beckman Coulter sent an Urgent Product Correction letter dated March 20, 2011, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignees were issued the following instructions: (1) If you suspect pregnant patient results were evaluated at your laboratory using only Total T4 to report thyroid status, consider reviewing Total T4 results reported in the last 9 months. Consult with your Laboratory Medical Director and requesting physician to resolve any concerns you may have regarding previously reported patient results during this time period. (2) Do not use the Access Total T4 assay as the only marker for evaluating pregnant patients for thyroid disorders. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded Access Total T4 reagent kits (Part Number 33800) to another laboratory, please provide a copy of this letter to them. (4) Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. For questions regarding this notice, consignees were instructed to contact Beckman Coulter Customer Support Center. (1) Via our website, http://www.beckmancoulter.com/customersupport/support (2) Via phone, call 1-800-854-3633 in the United States and Canada (3) Outside the United States and Canada please contact your local Beckman Coulter

Root cause

Other

Status

Terminated

Product code

KLI

Quantity affected

151,740 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Argentina Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic,

Date initiated

2011-03-10

Date posted

2011-04-12

Date terminated

2012-08-10

Location

Brea, CA

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