| Test Code | Test Name | Mnemonic | Manufacturer/ Vendor | Delay Dates | Delay Reason(s) | Client Communication |
|---|---|---|---|---|---|---|
| 0050105 | Thyroglobulin Antibody | ATHYG | Beckman Coulter | 05/2011 | National backorder of reagent; vendor initiated FDA recall. Specimens were held until clients were notified of testing changes in the Immediate Hot Line. Testing resumed on May 9, 2011, but additional time was required to complete the specimen backlog. |
Letter: May 18, 2011 |
| 0080515 | Myelin Basic Protein | MBP | Beckman Coulter | 03/2011– 05/2011 |
National backorder of reagent; the manufacturer moved production within the U.S. and was unable to meet the QC requirements at the new production site. ARUP worked directly with the manufacturer to resolve its QC issues. |
Letter: May 2, 2011 Letter: May 6, 2011 |
| 0020104 | Hepatitis C Virus Antibody (RIBA), Supplemental | HCVAB RIBA | Novartis/Ortho | 04/2011 | National backorder of reagent; reactivated on April 25, 2011. | Lab Focus: Inactivation of hepatitis C virus antibody (RIBA) and associated tests |
| 0070188 | Triiodothyronine, Reverse | RT3 | RADIM/PolyMedCo | 12/2010– 03/2011 |
National backorder of reagent; the sole-source manufacturer was unable to acquire supplies to produce reagent kits. Shipping delays due to weather, including the tsunami in Japan, the volcano in Europe, and storms in the U.S., impacted both production and part availability. Reagent kits were held in New York by U.S. Customs. Reagent kits were held in New York by FDA; weather issues affected ability of FDA staff to get to work. Due to the difficulty in obtaining test kits, many laboratories chose to discontinue RT3 testing, which resulted in a marked increase in test volumes for ARUP. |
Electronic notification: December 21, 2010
Electronic notification: January 4, 2011 |
| 0080515 | Myelin Basic Protein | MBP | Beckman Coulter | 12/2010– 03/2011 |
National backorder of reagent; the manufacturer moved production within the U.S. and was unable to meet their QC requirements at the new production site. An alternate kit (RIA) was evaluated and found not to be an equivalent test. |
Electronic notification: December 21, 2010 Electronic notification: January 4, 2011 Electronic notification: January 7, 2011 |
| 0093014 | Parathyroid Hormone-Related Peptide (PTHrP) | PTH RELPEP | Beckman Coulter | 10/2010– 02/2011 |
National backorder of reagent - manufacturer moved production from Texas to Prague and did not file the necessary paperwork for FDA approval. Testing was referred to another laboratory. | Electronic notification: October 15, 2010 Electronic notification: March 4, 2011 |