—#125055

Product

Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

FDA product code: JIX — Calibrator, Multi-Analyte Mixture
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K061923
Affected lot / code info: lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014.

Why it was recalled

Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

A recall notification letter, dated January 2014, was sent to Users.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2014-01-06
Posted by FDA: 2014-02-24
Terminated: 2015-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.