Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and

FDA device recall Z-1388-2012 · posted 2012-04-11 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may be as low as 50% of the serum recovery. Correct serum recovery has been confirmed for the affected lots. The issue is caused by the raw material lot (Poly-L-Lysin) instability. Poly-L-Lysin is the

Action taken

The firm, Roche Diagnostics Corporation, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 12, 2012 to all customers that received the affected lots of Elecsys Troponin I or Elecsys Troponin I STAT. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the affected product; discard the affected product from their inventory according to their site's local regulations; if their facility has distributed the affected product to other sites, ensure that this letter is provided to those sites; complete and return the attached fax form via fax to 1-888-912-8457 and file this letter for future references. If you have any questions about the information contained in this letter, please contact Roche Diagnostics Technical Support, 24 hours a day, seven days a week at 1-800-428-2336.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MMI

Quantity affected

1,288 kits

Distribution

Worldwide distribution. Argentina, Kenya, Austria, South Korea, Belgium, Kuwait, Bahrain, Morocco, Brazil, Mexico, Switzerland, Nigeria, Chile, New Zealand, Columbia, Philippines, Germany, Pakistan, A

Date initiated

2012-03-12

Date posted

2012-04-11

Date terminated

2013-02-06

Location

Indianapolis, IN

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