ClearanceBrief
Recall Z-0512-06 ยท MMI Immunoassay Method, Troponin Subunit

Roche Diagnostics Corp.

Roche brand Elecsys Troponin T; catalog number 2017644.

DateFeb 9, 2006 (initiated Jan 31, 2006)
StatusTerminated
ReasonA false negative result may be reported.
Root causeOther
ActionRecall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.
Quantity3116 kits
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K040733ELECSYS TROPONIN T STAT TEST
Roche Diagnostics Corp., May 17, 2004
K051752ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
Roche Diagnostics, Jul 11, 2005
K984105ELECSYS TROPONIN T STAT TEST
Boehringer Mannheim Corp., Dec 8, 1998