CLASS III Device recall · Reported 3 Apr 2013 · FDA Enforcement Report
Siemens Dimension Vista(R) Alkaline Phosphatase recalled
Siemens Healthcare Diagnostics is recalling Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in, distributed nationwide in the US. The recall was initiated on 10 Oct 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0988-2013
- FDA event ID
- 63494
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Oct 2012
- FDA classified
- 25 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Oct 2012 | Recall initiated by company | |
| 25 Mar 2013 | Classified by FDA | +166 days |
| 3 Apr 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Correlation slope bias and accuracy shift
Product as listed by the FDA
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Where it was distributed
Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisKansasLouisianaMassachusettsMarylandMichiganMissouriMississippiMontanaNorth Carolina
Questions about this recall
Is Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in on 10 Oct 2012. The recall is Class III and its status is Terminated. Recall number Z-0988-2013.
Why was it recalled?
Correlation slope bias and accuracy shift
Which lots are affected?
Lot 2AD052 Catolog KC330
Where was it sold?
Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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