ClearanceBrief
Recall Z-1227-2017 ยท LPS Urinary Homocystine (Nonquantitative) Test System

Siemens Healthcare Diagnostics, Inc.

N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocy

DateJan 11, 2017
StatusTerminated
ReasonThe firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
Root causeNonconforming Material/Component
ActionURGENT MEDICAL DEVICE RECALL Letter (PP17-005.A.US, dated 1/11/2016) was sent to the sole US consignee via FedEx on 1/11/2017 to notify the customer of the issue. All N Latex HCY OPAX03 lot 802907632 customers are being instructed to discard N Latex HCY OPAX03 lot 802907632. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the UMDR within 30 days. On 1/13/2017, an URGENT MEDICAL DEVICE RECALL letter (PP17-005.B.US, dated 1/13/2017) was sent to the sole US consignee with instructions to discontinue use of and discard the kit lot; complete & retu
QuantityUS: 62 kits; Foreign: 290 kits
DistributionWorldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Ara
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K052788N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
Dade Behring, Inc., Mar 29, 2006