Recall events
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Event 65224
Event summary
Timeline bucket May 14, 2013
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Siemens Healthcare Diagnostics, Inc
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
4 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 4
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Z-1512-2013
Recall number Z-1512-2013
Initiated May 14, 2013
Classification Class II
Status Terminated
Quantity 309 (100 test) kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1512-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6728]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Code information Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011
Distribution pattern Nationwide Distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[21340]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Z-1513-2013
Recall number Z-1513-2013
Initiated May 14, 2013
Classification Class II
Status Terminated
Quantity 3302 Kits (500 test)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1513-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[31344]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Code information Reagent Lot Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011
Distribution pattern Nationwide Distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16134]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Z-1514-2013
Recall number Z-1514-2013
Initiated May 14, 2013
Classification Class II
Status Terminated
Quantity 99 (2 pk)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1514-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[25894]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Code information Calibrator Lot Number: C5601 and C5602 Kit Lot Number/Exp. Date: 61405A01 27 Oct 2011 66517A02 27 Oct 2011 66611A02 27 Oct 2011 71997C02 27 Oct 2011
Distribution pattern Nationwide Distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16528]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Z-1515-2013
Recall number Z-1515-2013
Initiated May 14, 2013
Classification Class II
Status Terminated
Quantity 198 (6 pk)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1515-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[37046]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Code information Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011
Distribution pattern Nationwide Distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16544]
FDA event record
· Exact recall-number query on openFDA
