Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 14, 2014
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems
Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc recalled Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 0636797… - a moderate-severity action.
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 0636797… was recalled by Siemens Healthcare Diagnostics, Inc in May 14, 2014. Reason: Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole bloo…. Check the official notice for the remedy. Verify recall #Z-1564-2014 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc issued this moderate-severity FDA Devices recall-Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole bloo….
- Moderate
- severity level
- 49K units
- affected scope
- Class II
- classification
- May 14, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1564-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1564-2014) was formally reported on May 14, 2014, with the manufacturer initiating the action on March 25, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc is listed as the recalling firm, operating out of East Walpole, MA. Federal records list the affected scope as 49123 units.
The documented reason for this recall is: Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223 Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland Finland France Fren.Polynesia Germany Great Britain Greece Guadeloupe Hungary Iceland I…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
49123 units
Related Recalls
6
3 from same agency
Product description
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems
Reason for recall
Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1564-2014 |
| Date reported | May 14, 2014 |
| Date initiated | March 25, 2014 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Firm location | East Walpole, MA |
| Affected scope | 49123 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland Finland France Fren.Polynesia Germany Great Britain Greece Guadeloupe Hungary Iceland Ireland Israel Italy … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1564-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 49123 units.
Why was this product recalled? ▼
Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2014. Severity: Moderate. Recall number: Z-1564-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland Finland France Fren.Polynesia Germany Great Britain Greece Guadeloupe Hungary Iceland Ireland Israel Italy Latvia Lithuania Luxembourg Malta Martinique Netherlands Norway Poland Portugal Qatar Reunion Romania Russian Fed. Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1564-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 14, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.