CLASS II Device recall · Reported 26 Jun 2013 · FDA Enforcement Report
Vitros Chemistry Products-HCY Reagent recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products-HCY Reagent, distributed nationwide in the US. The recall was initiated on 1 Apr 2013 and the FDA has classified it as Class II.
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-1556-2013
- FDA event ID
- 64874
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2013
- FDA classified
- 18 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Apr 2013 | Recall initiated by company | |
| 18 Jun 2013 | Classified by FDA | +78 days |
| 26 Jun 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is recalling the specific lot due to lower than expected results.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Where it was distributed
Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
Nationwide ArkansasArizonaCaliforniaColoradoConnecticutFloridaHawaiiIdahoIllinoisKentuckyLouisianaMaineNew JerseyOklahomaPuerto RicoTennesseeTexasWashingtonWest Virginia
Questions about this recall
Why was it recalled?
The firm is recalling the specific lot due to lower than expected results.
Which lots are affected?
Lot # 1529-17-2636, expiration date 12 June 2013
Where was it sold?
Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ortho-Clinical Diagnostics
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| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
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