Recall Z-0039-2017— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0039-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-03

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-08-03, terminated 2017-05-11. It names one FDA 510(k) clearance: K061792. Product: Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB. Reason: Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-03
Terminated: 2017-05-11
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K061792 — DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRIDade Behring, Inc.·cleared 2006-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB

Reason for recall

Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.

Data sourced from openFDA. This site is unofficial and independent of the FDA.