The Recall Desk

FDA (Devices) recall action 63682

Siemens Healthcare Diagnostics, Inc recalled 7 products on 2012-12-19

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2012-12-19
Critical
0
Units
12,976

Why these products were recalled

Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • ModerateFDA (Devices)··2012-12-19

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur CA 19-9 assays because room temperature changes can alter test results.

    Product
    Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA…
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    0 states
  • ModerateFDA (Devices)··2012-12-19

    Siemens Healthcare Recalls ADVIA Centaur Theophylline 2 Assay Kits

    Siemens Healthcare is recalling ADVIA Centaur Theophylline 2 assay kits because room temperature changes may affect test results.

    Product
    Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP…
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    0 states
  • ModerateFDA (Devices)··2012-12-19

    Siemens ADVIA Centaur Folate Assay Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur Folate assays because room temperature changes can alter test results.

    Product
    Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood…
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    0 states
  • ModerateFDA (Devices)··2012-12-19

    Siemens ADVIA Centaur Digitoxin Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur Digitoxin tests because room temperature changes may affect assay results.

    Product
    Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
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    0 states
  • ModerateFDA (Devices)··2012-12-19

    Siemens Healthcare BNP Test Kit Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling BNP test kits because room temperature changes may affect assay results on ADVIA Centaur systems.

    Product
    Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and…
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    0 states
  • ModerateFDA (Devices)··2012-12-19

    Siemens Healthcare Recalls CA 27.29 Assay Kits Due to Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur BR Assay kits for CA 27.29 because room temperature changes can alter test results.

    Product
    Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum…
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    0 states
  • ModerateFDA (Devices)··2012-12-19

    Siemens ADVIA Centaur DHEAS Assay Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur DHEAS assays because room temperature changes can alter test results.

    Product
    Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA…
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    0 states