Cresolphthalein Complexone, Calcium

Dimension Vista Calcium (CA) Flex reagent cartridge

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.

ABX PENTRA Calcium CP Reagent, Model # A11A01633

HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.

Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Cor

The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401.

Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation, Indianapolis, IN.

Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of precipitate in the R2 of the affected calcium reagent lots. The precipitate observed was classified as o-cresolphthalein complexone (o-CPC), a reactive component of the calcium R2. The root cau

Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium R

Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.

Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hit

Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.

Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hit

Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.

Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.

Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160

May produce erroneously low results from specific well sets.