FDA event 65162 · Recall Observatory

device · product 1 of 6

ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Z-1881-2013

Recall number: Z-1881-2013
Initiated: May 10, 2013
Classification: Class II
Status: Terminated
Recalling firm: Siemens Healthcare Diagnostics, Inc
Quantity: 172913

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A rare variant of TSH, identified in a small cluster of patients, is not detected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A rare variant of TSH, identified in a small cluster of patients, is not detected.

Code information

Per recall strategy.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.

device · product 2 of 6

Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Z-1882-2013

Recall number: Z-1882-2013
Initiated: May 10, 2013
Classification: Class II
Status: Terminated
Recalling firm: Siemens Healthcare Diagnostics, Inc
Quantity: 39763

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A rare variant of TSH, identified in a small cluster of patients, is not detected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A rare variant of TSH, identified in a small cluster of patients, is not detected.

Code information

Per recall strategy.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.

device · product 3 of 6

Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Z-1883-2013

Recall number: Z-1883-2013
Initiated: May 10, 2013
Classification: Class II
Status: Terminated
Recalling firm: Siemens Healthcare Diagnostics, Inc
Quantity: 33506

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A rare variant of TSH, identified in a small cluster of patients, is not detected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A rare variant of TSH, identified in a small cluster of patients, is not detected.

Code information

Per recall strategy.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.

device · product 4 of 6

Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Z-1884-2013

Recall number: Z-1884-2013
Initiated: May 10, 2013
Classification: Class II
Status: Terminated
Recalling firm: Siemens Healthcare Diagnostics, Inc
Quantity: 18584

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A rare variant of TSH, identified in a small cluster of patients, is not detected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A rare variant of TSH, identified in a small cluster of patients, is not detected.

Code information

Per recall strategy.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.

device · product 5 of 6

IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Z-1885-2013

Recall number: Z-1885-2013
Initiated: May 10, 2013
Classification: Class II
Status: Terminated
Recalling firm: Siemens Healthcare Diagnostics, Inc
Quantity: 51792

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A rare variant of TSH, identified in a small cluster of patients, is not detected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A rare variant of TSH, identified in a small cluster of patients, is not detected.

Code information

Per recall strategy.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.

device · product 6 of 6

IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Z-1886-2013

Recall number: Z-1886-2013
Initiated: May 10, 2013
Classification: Class II
Status: Terminated
Recalling firm: Siemens Healthcare Diagnostics, Inc
Quantity: 13462

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A rare variant of TSH, identified in a small cluster of patients, is not detected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A rare variant of TSH, identified in a small cluster of patients, is not detected.

Code information

Per recall strategy.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.

Event 65162

Event summary

Source snapshots represented here

Every recalled product in this event

ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Reason for recall

Code information

Distribution pattern

Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Reason for recall

Code information

Distribution pattern

Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Reason for recall

Code information

Distribution pattern

Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Reason for recall

Code information

Distribution pattern

IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Reason for recall

Code information

Distribution pattern

IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Reason for recall

Code information

Distribution pattern

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