Access Total T4 Calibrator, Catalog No. 33805
USAccess Total T4 Calibrator, Catalog No. 33805
Recalling Firm: Beckman Coulter, Inc.
Grund für den Rückruf / Gefahr
TranslatedBeckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
Produktbeschreibung & Identifikation
TranslatedAccess Total T4 Calibrator, Catalog No. 33805
Additional Source Details
| Field | Value |
|---|---|
| City | Chaska |
| State | MN |
| Event id | 98591 |
| Address 1 | 1000 Lake Hazeltine Dr |
| Address 2 | N/A |
| Code info | UDI-DI 15099590225872 Lots 538729, 538815, 538898, 539107, 539243 |
| Postal code | 55318-1037 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 2068 US, 2830 OUS |
| Reason for recall | Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260316 |
| Initial firm notification | Letter |
| Center classification date | 20260422 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Access Total T4 Calibrator, Catalog No. 33805?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Übersicht
- Rückrufendes UnternehmenBeckman Coulter, Inc.
- StatusOngoing
- RisikostufeClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Austria, Bangladesh, Bolivia (Plurinational State of), Bosnia and Herzegovina, Brazil, Canada, China, C¿te d'Ivoire, Croatia, Czechia, Denmark, Egypt, El Salvador, Ethiopia, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Kosovo, Lebanon, Libya, Malawi, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, Uzbekistan, Viet Nam, Yemen.
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🚨 SAFETY ALERT: Beckman Coulter, Inc. - Access Total T4 Calibrator, Catalog No. 33805 Check if your household is affected: https://therecallfile.com/de/recalls/access-total-t4-calibrator-catalog-no-33805/FDA-Z-1922-2026
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